Advertisement

Topics

Evaluation of Stool Tagging for Improved Patient Compliance

2014-07-23 21:51:10 | BioPortfolio

Summary

Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. The investigator's prior work demonstrated that the bowel preparation was the least tolerable aspect of colorectal evaluation when compared to the CT colonography and optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel preparation, with fewer false positives due to retained stool-mimicking polyps.

The researchers hypothesize that image quality and patient preference will vary with stool tagging concentration and dosing schedule. The researchers propose to evaluate specific stool tagging protocols with the following aims:

AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal evaluation.

AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across stool tagging protocols for the outcome measures of patient preference, image quality in the presence of tagging, and diagnostic reader performance.

The researchers will use specific variations in stool tagging techniques to determine the best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest patient acceptability, as well as evaluate the adequacy of preparation for same-day colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat adenomas. Most importantly, these results will help inform the design of a larger trial of an optimized CT colonography technique in a community setting.

Description

CT Colonography, a rapidly evolving technique, offers a noninvasive and efficient colorectal screening examination, with the potential to improve patient compliance. However, currently it requires the bowel preparation, one of the largest barriers to colonoscopy screening. A promising new tool in CT Colonography is stool tagging, which has the potential to decrease the amount of catharsis required by patients during the bowel preparation, while decreasing the number of false positives due to the reader mistaking residual stool for polyps.

Our primary hypothesis is that image quality and patient compliance differ depending upon the tagging agent and dosing schedule. Our strategy is to vary key components of recently reported barium and iodine protocols to further optimize them and to compare our results with existing and currently aggregating data in collaboration with other investigators.

The following aims will implement this strategy:

AIM 1: Perform a randomized control trial of specific stool tagging protocols at CT Colonography in a well characterized cohort of patients undergoing colorectal evaluation.

Task 1A - Recruit a prospective cohort of 60 subjects, randomize them equally to three different stool tagging protocols, and sequentially perform CT Colonography and optical colonoscopy on them.

Task 1B - Assess image quality of CT Colonography and optical colonoscopy data by the method of bowel preparation in the first five subjects of each arm and implement specific changes, if necessary.

AIM 2: Analyze the CT Colonography and optical colonoscopy data to assess differences across study arms for the outcome measures of patient preference, image quality of tagged stool, and diagnostic reader performance.

Task 2A: Assess patient expectations regarding the bowel preparations, CT Colonography and colonoscopy before the procedures and their preferences after the procedures.

Task 2B: Evaluate image quality, in the presence of tagged stool and fluid, of both the CT data and the colonoscopy data.

Task 2C: Perform a multi-observer reader evaluation of diagnostic performance of CT Colonography and colonoscopy, compared to the enhanced reference standard of colonoscopy aided by segmental unblinding of CT results, to assess sensitivity and specificity of colorectal polyp detection.

Upon completion, the three specific variations in stool tagging techniques will be compared on homogenous density of tagging and patient acceptability to determine which protocol optimizes the trade-off. Diagnostic performance of CT and colonoscopy will be compared to the enhanced reference standard of colonoscopy aided by the segmental unblinding of CT results. Most significantly, these results may help determine an optimal tagging protocol to use for larger trials of CT Colonography implementation in community settings.

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Prospective

Conditions

Colon Cancer

Intervention

Imaging procedure of CT colonography

Location

Diagnostic Imaging Associates
Chesterfield
Missouri
United States
63017

Status

Recruiting

Source

Center for Diagnostic Imaging

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:51:10-0400

Clinical Trials [1911 Associated Clinical Trials listed on BioPortfolio]

Magnetic Resonance (MR) Colonography With Fecal Tagging

The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR co...

Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may ...

Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography

The purpose of this study is to diagnose possible synchronous carcinomas and polyps with MR colonography in patients booked for operation because of carcinoma in the descending or sigmoid ...

Preoperative Assessment of Colon Tumor

The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcino...

Colon Investigation - Factors Determining Choice of Procedure

Registration of patients referred for colon investigation by barium enema, CT colonography and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period of mi...

PubMed Articles [22144 Associated PubMed Articles listed on BioPortfolio]

Colon cancer with rapid growth in 16 months confirmed by computed tomographic colonography.

This report describes a case of rapidly growing colon cancer confirmed by computed tomographic colonography (CTC). A 75-year-old woman presented at our clinic with complaints of abdominal discomfort a...

Clinical Value of CT Colonography Versus Preoperative Colonoscopy in the Surgical Management of Occlusive Colorectal Cancer.

CT colonography (CTC) has been recognized as a complementary approach to evaluating the entire colon after incomplete colonoscopy (IC) in patients with occlusive colorectal cancer (CRC). The objective...

Diagnostic value of magnetic resonance versus computed tomography colonography for colorectal cancer: A PRISMA-compliant systematic review and meta-analysis.

Advanced colorectal cancers were associated with poor prognosis, and early diagnosis was important for high-risk patients. Colonography is commonly used for diagnosing colorectal cancer. However, a fe...

PRE- AND POSTOPERATIVE IMAGING METHODS IN COLORECTAL CANCER.

Among the screening tests for colorectal cancer, colonoscopy is currently considered the most sensitive and specific technique. However, computed tomography colonography (CTC), magnetic resonance imag...

Causes of mortality in older patients with stage 3 colon cancer.

Life expectancy plays a key role in the selection of patients with stage III colon cancer for adjuvant chemotherapy, but little is known about causes of mortality in older patients with colon cancer. ...

Medical and Biotech [MESH] Definitions

A non-invasive imaging method that uses computed tomographic data combined with specialized imaging software to examine the colon.

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

The segment of LARGE INTESTINE between the CECUM and the RECTUM. It includes the ASCENDING COLON; the TRANSVERSE COLON; the DESCENDING COLON; and the SIGMOID COLON.

The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.

A surgical procedure which diverts pancreatobiliary secretions via the duodenum and the jejunum into the colon, the remaining small intestine being anastomosed to the stomach after antrectomy. The procedure produces less diarrhea than does jejunoileal bypass.

More From BioPortfolio on "Evaluation of Stool Tagging for Improved Patient Compliance"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial